International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors
Both
Solid Tumors
Trial Information
International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus
Inclusion Criteria:
- Metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach
or the lower esophagus proven by histology
- CLDN18.2 expression of the biopsy material from the cancer confirmed by
immunohistochemistry
- At least 1 measurable site of disease according to RECIST criteria
Exclusion Criteria:
- Less than 3 weeks since prior chemo-or radiation therapy
- Other concurrent anticancer therapies
- Concurrent anticoagulation with vitamin K antagonists
- Therapeutic doses of Heparin (prophylactic doses accepted)
- Uncontrolled or severe illness
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of remission (CR, PR) according to RECIST Criteria
Outcome Time Frame:
All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Safety Issue:
No
Principal Investigator
Martin Schuler, Prof. Dr. med.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Innere Klinik Universitätsklinikum Essen
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
GM-IMAB-001-02
NCT ID:
NCT01197885
Start Date:
September 2010
Completion Date:
December 2013
Related Keywords:
- Solid Tumors
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